A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-05

Study Completion Date

2020-02-28

Brief Summary

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The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.

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Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OTX-DP

Group Type EXPERIMENTAL

Dexamethasone, 0.4mg

Intervention Type DRUG

Ophthalmic Insert

Placebo

Group Type PLACEBO_COMPARATOR

Placebo plug with no drug

Intervention Type DEVICE

Ophthalmic Insert

Interventions

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Dexamethasone, 0.4mg

Ophthalmic Insert

Intervention Type DRUG

Placebo plug with no drug

Ophthalmic Insert

Intervention Type DEVICE

Other Intervention Names

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OTX-DP

Eligibility Criteria

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Inclusion Criteria

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria

* History of refractive surgery (including LASIK procedures) within the past 2 years
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* History of IOP increase as a result of steroid treatment
* A female who is currently pregnant, planning a pregnancy, or lactating

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No